Sr. Supplier Quality Engineer

Zimmer Biomet•Englewood, CO

54d•$90,000 - $110,000•Hybrid

About The Position

Paragon 28, a Zimmer Biomet Company is hiring a Sr Supplier Quality Engineer. The Sr. Supplier Quality Engineer is a quality engineering position that has emphasis on developing and maintaining Paragon 28's supplier quality system and related quality activities specifically relating to product development, manufacturing, and supply chain of Paragon 28 orthopedic products for the Foot and Ankle. This is hybrid position located at our Englewood, Colorado location.

Requirements

Bachelor's degree in Engineering or technical discipline
4+ years in related field, preferably medical device or manufacturing
Auditing experience, ISO 13485 preferred
Proficient in Machining methodologies (Titanium and Stainless-Steel experience best), knowledge of hardness, passivation, surface treatments, cleaning techniques etc. for communication with Suppliers and Engineers.
Familiarity with 21 CFR 820 and ISO 13485 and other Government / ISO Standards
Technical writing skills that include Quality Management Systems (QMS) and procedures
Proficient in Geometric Dimensioning and Tolerancing (GD&T) preferable
Process Validation experience
Basic Computer Skills (MS Office)

Responsibilities

Process Owner for Key Quality Processes: Supplier Management
Lead supplier qualification process. Interface with suppliers to ensure product compliance to specification and perform supplier audits as needed.
Develop measurement techniques for product release at suppliers.
Participating on project teams as a contributing member by providing supplier quality engineering support in the development of new suppliers and processes, and continuously improving company's products and suppliers.
Provide support for the manufacturing areas (external). Work with production personnel and supervision to determine and monitor quality metrics, samples plans and address non-conforming product issues. Lead corrective and preventive action investigations to resolve the root cause of problems.
Auditing suppliers on time and per schedule
Writing audit plans and audit reports for suppliers to all applicable standards and regulations
Writing and reviewing of procedures, plans, protocols and reports to ensure regulatory compliance.
Perform Mechanical Inspections and use typical equipment used in inspection.
Assist with Design Transfer for release of new product development projects.
Author and/or assist in the development and execution of process validations at suppliers
Perform statistical analysis for testing requirements and develop MSAs, TMQs, and inspection correlations.
Assist suppliers in completion of Supplier Corrective Actions per appropriate timelines
Assisting project teams on compliance with purchasing requirements per FDA QSR, European MDD/MDR, ISO 13485 and other applicable ISO/EN standards
Capture and calculate supplier metrics on a regular basis
Develop relationships with employees and suppliers to ensure team-oriented operation.
Accurately represents quality processes to 3rd party auditors (FDA, ISO 13485, MDSAP, etc.)
Other duties as assigned